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C720 : Molecular Biology

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C720 : Molecular Biology

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Course Code: C720
University: The University Of Edinburgh

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Country: United Kingdom


Module 5: Translation of ‘omics-based tests from discovery to healthcare

1. How are ‘omics-based tests different to single gene tests?  In your answer include both the technical differences (briefly) and ethical considerations.
2. What do you believe are the biggest challenges for the translation of ‘omics-based tests to health care?
3. Name at least two ‘omics databanks (one that is mentioned in the NHMRC document, and one from another module) and describe what data they contain.
4. What government agencies are responsible for each of the following: (Australia)
i)   Regulation of genetic testing, including ‘omics-based tests
ii)  Accreditation of pathology laboratories.

Module 6: Practising Pathology in the Era of Personalised Medicine

1. What is YOUR definition of personalised medicine?
2. What technique would YOU use to assign a patient with melanoma to one of the molecular classifications listed in Figure 1 of the Gu& Taylor (2014) paper? Justify your choice.


Differences between omics-based and single-gene tests
The omics-based test is considered to be a complex type of biomarker test. The test uses various defined set of measurements combined with a precisely defined computational model for a clinical test for biomarkers. ‘Omics-based test is used to cover issues which are related to clinical trial design, specimens, mathematical modeling, ethical, regulatory aspects. This test is used in hospitals to guide patients on some healthcare activities and clinical tests. They provide great characteristics of infection which allow a patient better understand the diseases and be able to predict their health status and therefore they are in a position to select the therapy which beat suits their condition. Single gene test, on the other hand, is done in cases where there is high clinical suspicion for a particular type of gene been present in a patient. They are used in the previous negative genitive testing if it was not included in the analysis. As compared to ‘omics-based single gene test is very cost effective, and is not complicated because the exercise is simple and healthcare professionals do not end unnecessary testing genes which are not required. However-unlike ‘omics-based tests which enable patients aware of all the health risk which surrounds the society, single gene test lacks this capability as patients are only taught about the healthcare risk which is currently in the clinical concern.
Challenges for translation of omics-based test to health care
Healthcare institution has been experiencing a lot of problems like trying to adopt the omics-based test in the system; this is because they are very complex as they involve analyzing a significant amount of DNA dataset using a complex computational algorithm which most of the healthcare professionals do not know. Health institution, therefore, incur a lot of costs as they try to get professional in this field and sometimes they even have to employ them from other countries in which they have to pay a lot of tax. With the translation of omics-based test in hospitals has made it difficult to predict the final biological impact of DNA with the use of a single analysis because the test requires a lot of computational data for review to be able to come up with appropriate results. Use of ‘omics tests in hospitals can lead to over diagnosis of certain infections which can lead to over treating and sometimes this can affect the health of the patient. Just like any other test, ‘omics-based testing can sometimes give false results which can make healthcare professionals make the wrong decision about an infection.
Omics databanks
Omics data banks should contain some suitable standards which can clearly define the ethical consideration of the information they hold for privacy purposes. Therefore, omics databanks have led to the implementation of governance standards which are required for the privacy of individuals. This has made it easy to track patient’s data and medical records by medical professionals. In case the patient’s data has to be shared, governance standards ensure that it is done more accurately. Access to ‘omics data should be treated with respect and responsible manner. There are various benefits of sharing omics data with the public as it provides knowledge and enhances the quality of data control. However, this has to be done in limited situations, specifically which are about protection of patients privacy. And lastly, databanks should have rules or data storage and security. This is to ensure that the patient’s information is kept private and insecure places where unauthorized users can’t have access to as they can change the meaning of the information. For an individual to have access to the information, they must be authorized, and they are not allowed to share the information with other parties. Databanks should be designed in such a way that data can be retrieved in case of failures, and therefore, top IT specialist is charged with this responsibility to ensure patients data does not get lost.
The databank mentioned in the NMHRC document is public databank. The databank keeps documents containing public information and facilitates an increased discovery and knowledge as well as data quality control. Other types of databanks are Forensic DNA databanks which store information of people in developed countries such as USA to facilitate direct comparison of DNA profiles of evidence samples. The information from these databanks is widely used in the field of law to ensure that suspects do not escape after committing felonies.
Regulation of genetic testing, including ‘omics-based tests
Genetic tests look at DNA material which carries our bodies’ instructions necessary for growth, development, and functionality. To conduct genetic tests including ‘omics-based tests, an organization has to go through a strict review by the Australian governing the registration and provision of human genetic tests with the country. The Australian government is responsible for controlling all the DNA tests because the information is high and should be handled with maximum care by licensed and recognized practitioners. DNA tests are done with the consent of the people involved because the information from the tests can revoke numerous issues within families leading to breakages. ‘Omics-based tests are aimed for establishing if a test aligns with the presence or absence of a risk of a given disease to facilitate effective diagnosis. Different government agencies are responsible for regulation of genetic testing involving ‘omics-based tests and Accreditation of pathology laboratories. The agency liable for regulating genetic testing, including ‘omics-based tests, are; The National Health and Medical Research Council (NHMRC). The agency is responsible for ensuring that nurses and physicians have a good understanding of ‘omics and its practice.
ii)  Accreditation of pathology laboratories
Pathology laboratories examine the samples of body tissues for diagnosing the cause and effects of a disease. Pathology laboratories are of different categories which range from general, medical and specialized laboratories. A public laboratory category works under the supervision of a pathologist. Medical laboratories work under the medical practitioner while a specialized laboratory works under the control of a person with specialized skills. For a pathology lab to operate within the Australian environment, it has to be licensed and recognized by the responsible government agency. To become eligible to operate pathology laboratory, on has to be accredited by the National Association of Testing Authorities (NATA) before application of the certified pathology laboratory.   
Personalized medicine
Over the past few decades, there has been a progressive improvement in the medicine. Medical researchers have been able to explore a different cure for various diseases with the use of drugs, vaccines, and surgical techniques. This has led to the improvement of healthcare standards and hence the human lifespan in general. All this has tailored the route to personalized medicine in which patient receives his/her treatment based on the characteristics of their illness. However, this does not mean that there is the creation of drugs and medicals devices for a specific individual, but it merely means that people are divided into subpopulation based on their illness characteristics. Patients with the same illness are kept in the same subpopulation (Chai, Pillay, Badrick, Bennetts & Horan, 2018). Due to differences in the human genome, a medical treatment which includes drugs, diagnosis and therapies are designed for a specific group o people in the society. Scientists have been able to use the human genome to cure intransigent diseases like such as cancer. This has enabled us to determine the prospect of personalized medicine. Through development research institutions, use of personalized medicine has led to the creation of more subpopulation which has helped healthcare professionals have the capability of curing more mixed infections as diabetes, cancer and heart diseases. Because inherited genes from our parents determine our health, it can be easy for cancer be transmitted from one generation to another in a specific family. Personalized medicines come in to treat this kind of diseases as they already have a subpopulation. This has also greatly helped in determining individual risk of developing this health complication so that preventive measure can be used against them. Personalized medicine has been used in maximizing the value of drugs which a country spend each year.
The technique used to assign a patient with melanoma to molecular classification
Melanoma is a dangerous form of skin cancer which has been increasing in the society as time passes by. Though recent treatments have been developed to control and manage the infection, the infection requires the patients to go through some therapies as treatments rarely cure the disease. Health professionals need to identify the genetic mutation responsible for the disease so that appropriate treatment can be given. It is clear that multiple molecular subtypes of melanoma exist. Healthcare professionals have been able to assign patients to molecular classification by recognizing and assigning different genetic mutations to subpopulation so that the appropriate measurement and treatment can be given to the subpopulation. There is only two kind of drugs which are capable of healing metastatic melanoma which is a chemotherapeutic agent dacarbazine and immunomodulatory cytokine interleukin-2 even though melanoma is an aggressive tumor which can also resist therapies.

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